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Clinical Trials/NCT01936714
NCT01936714
Completed
Not Applicable

Comparison of Two Phacoemulsification-methods: Low Fluidic EasyTip 2.2mm vs. High Fluidic EasyTip 2.2mm

Medical University of Vienna1 site in 1 country50 target enrollmentFebruary 2013
ConditionsCataracts

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataracts
Sponsor
Medical University of Vienna
Enrollment
50
Locations
1
Primary Endpoint
phacoemulsification time
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
September 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rupert Menapace

Ao.Univ.-Prof. Dr.med.univ.

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • bilateral age-related cataract
  • good overall physical constitution

Exclusion Criteria

  • previous intraocular surgery or ocular trauma
  • previous corneal pathology
  • previous endothelial cell count \<1200
  • diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
  • intraocular complication like posterior capsular
  • postoperative comlpications (e.g. postoperative uveitis)

Outcomes

Primary Outcomes

phacoemulsification time

Time Frame: intraoperative

time spent for the phacoemulsification process was the phacoemulsification tip time (PTT) needed to divide the nucleus and the PTT needed to conquer it

effective phacoemulsification time

Time Frame: intraoperative

time in seconds required had 100% power been used throughout the phacoemulsification process documented for the separation of the nucleus (divide) and the aspiration of the quadrants (conquer)

fluid volume

Time Frame: intraoperative

amount of BSS used for dividing and conquering

Secondary Outcomes

  • postoperative corneal oedema(1 day, 1 week, 6 months)
  • postoperative endotheial cell loss(6 months)

Study Sites (1)

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